On Tuesday night, November 10th, ABC World News aired a story that was a follow-up to their June 2nd, 2009 report on personalized cancer care. Tuesday’s report featured Bill Shuette, the gentleman I had the pleasure of meeting last week. Click here to see the report. When the story about my response to PF-02341066 aired in June, there was a flurry of interest in this new “wonder” drug. Many people were disappointed that this treatment was not the answer for them or their loved ones. However, for a handful of people, it was indeed a lifesaver. Bill is among them.
Once again, message boards are heating up with interest, and I would presume that MGH and other facilities that are sponsoring the third phase of the PF-02341066 trial will field many phone calls. As the ALK mutation occurs in a minority of lung cancer patients (3-7% of lung cancers, adjusted up to c. 13% for light to never-smokers), this treatment will not be appropriate for the majority. However, I have no doubt it will prove a godsend to some.
Traffic on my blog was much heavier yesterday, with many people logging on to read about PF-02341066. As I have been on trial for more than 13 months now, I am in a somewhat unique position to provide the perspective of a trial participant, or subject. This is, of course, not to be confused with medical advice which I am not qualified to give. What I can do though, is tell you about my own experience with this drug. Let’s pretend I am being interviewed:
How is the drug administered?
The drug is in capsule form. At this stage of the trial, 250mg twice a day is the standard dosage, as it was when I entered the trial. I take three gray capsules in the morning, and three more at night.
The first time you took the pills, what did it feel like?
I felt a little woozy; just a bit different or altered. I had severe diarrhea within an hour, as well as mild nausea. The diarrhea cleared up after several episodes that day, as well as administration of some immodium, and it was not an issue again. I felt somewhat fatigued as well.
Were there potentially more severe side effects as well?
My heart rate was monitored very closely initially, and at one point I had a questionable EKG (mild arrhythmia). It happened once and and proved to be a non issue. There was also the potential for liver inflammation, and my liver enzymes rose sharply after a few weeks. They never reached a dangerous level of concentration, and quickly began to decrease before settling at a slightly elevated level where they remain. It is interesting to note that when I had to take a holiday from the drug during surgery for my ankle, my enzymes dropped to a level that was very close to normal. Perhaps a week after the onset of regular dosing, I awoke with a very noticeable visual disturbance: it was as if everything had a light trail or ghost image. This effect was most noticeable in low light conditions, and/or when I was transitioning from dark to light. I would eventually learn that this is a condition called palinopsia and is a side effect of certain drugs.
What were the positive effects and how quickly did you notice them?
When I started the trial, I was coughing almost constantly and was noticeably short of breath. When I lay down at night my lungs “rattled” in a way that was all too familiar: I knew it was the cancer. I could tell that my immune system was depressed in general, as I had begun to have secondary infections and to feel crummy all the time. It was obvious to me that I was dying, and it was scary as hell.
The first dose of PF-02341066 was a lead-in dose. This meant that a whole week passed before I began daily dosing. Within days of taking the full dose, all of the above symptoms began to fade. It was truly amazing. By two weeks, I had no cough and I could breathe so much more freely.
Were there lingering negative side effects?
Nausea hasn’t been a big issue for me, but I do have days where I am queasy and on two occasions I have vomited. In the beginning, as a variation on the trial, we were not allowed to eat for several hours before and after taking the capsules, and the nausea was much more bothersome. Taking the drug on a full stomach definitely helps. For perhaps the first eight months, I would seem to hit a wall of fatigue at about 8 pm. I have noticed that exercising actually makes this fatigue far less noticeable, and I can stay up until 9 pm now–even stretching it to 10 some nights. I definitely require more sleep than I once did; perhaps averaging ten hours a night. After a few months, I became aware that the peripheral neuropathy in my feet and hands (a lingering result of chemotherapy) was more noticeable again. I am no longer so aware of it. The palinopsia, or visual disturbance is not so noticeable either, although driving at night is more challenging than it once was. I am unsure as to whether or not these side effects have actually lessened, or if my brain has simply adjusted to a new reality.
After several months of being on trial, I had a very sharp pain in my chest upon swallowing and I coughed up a small amount of blood. After questioning me about my symptoms, Dr. Shaw felt that it was esophageal in origin. A look down my throat with a scope confirmed the presence of an esophageal ulcer; likely as a result of an incompletely swallowed capsule. It was quickly resolved with several doses of Carafate. I now make sure to drink lots of water with my pills and I usually take a bite of something as well (such as applesauce) to make sure they all went down.
One interesting, if benign, side effect has been a sharply increased sense of smell. I can smell everything now with such acuity, that I feel kind of like a bloodhound. There are situations where this is not a good thing, but for the most part I enjoy this sharpened perception.
And how about lingering positive side effects?
Oh yeah. I feel great. Better than I have in years. I am strong, my immune system is in balance and perhaps more vigorous than it had been previously. I wake up every morning and sing a little song. It goes something like this: “I’m alive, I’m alive, I’m alive.”
What lifestyle changes has enrollment in this clinical trial entailed?
Well, obviously I commute to MGH in Boston with greater frequency. In the beginning, it was somewhat intense, but now I go once a month for PK’s (pharmacokinetics), a physical with Dr. Shaw and to pick up my drug supply. I have spiral CT scans every two months. I must obtain an ok for any new drug, prescription or over the counter, with the trial team before I take it. Because of my slightly elevated liver enzymes, I avoid hard alcohol for the most part (occasional teeny martinis and wee margaritas), but still drink red wine in moderation. It is necessary to record the time I take my drug each morning and evening as well as the time of the meal just prior. This is certainly the most tedious part, and I am not always good at remembering. Once or twice I have forgotten to take my dose of PF-02341066 as well. Luckily, it has a rather long half life, and I have simply waited until the next dose (per my doctor’s recommendations). And sadly, I can no longer eat grapefruit or drink grapefruit juice, as it interacts in a negative way with the drug. Ending on a truly positive note; my ability to travel, exercise, and go about my daily life has in no way been restricted. Although, when I broke my ankle Marguerite and Jose did tease me that there was a “no broken bones” clause in my clinical trial contract.
So is PF-02341066 really a miracle cure for cancer?
No. It is not a cure. Because I have a mutation of the EML4-ALK gene, my body would again manufacture cancerous cells if I were not taking an ALK inhibitor such as PF-02341066. This is referred to as onco-addiction: tumor cells are dependent on activated oncogenic signaling pathways, and the ALK inhibitor disrupts this process.
How long will it work for?
We are on a frontier here: so the correct answer is that no one knows for sure. EGFR inhibitors have been effective for some individuals for several years and in some cases, longer. However, it is not unlikely that eventually the cancer will “find a way around” these inhibitors. The fact that I have had stable scans for 13 plus months is a good sign, and I have a gut feeling that the cancer will be held at bay for some time.
So what then?
I can only hope that PF-02341066 will continue to be effective for a long time, and that other drugs that target ALK (and other mutations, for those who are ALK negative) are in the pipeline. In the meantime, I have been given the gift of more time, and each day is precious. I also have the satisfaction of knowing that my enrollment in a clinical trial has in some way contributed to the search for more effective treatments for lung cancer, and, perhaps eventually, for some a cure.
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At dusk the past two days, the moon has risen just over the lake, turning the water a shimmery silver. When I have awakened in the middle of the night , it has been to a world transformed: moonlight has bleached most everything a bluish white except for what it cannot reach, and that is in deep shadow.
I had been receiving scans every three months for three years at the time of the September 2008 scan. They had gone from questionable to progressively worse. “Interval increase in size and number of multiple bilateral pulmonary nodules is consistent with progression of metastatic disease”, read a report from August of 2007.
life and breath: outliving lung cancer 